Bifurcation stent delivery system

ABSTRACT

The present invention is drawn to a system for deploying a stent at a bifurcation. In one embodiment, the system includes a stepped balloon which has a first section of a first diameter, and a second section of a second diameter. The first portion is sized to deploy a first stent portion, having a larger deployed diameter, while the second portion is sized to deploy a second stent portion, having a smaller deployed diameter.

INCORPORATION BY REFERENCE

The following patent is hereby fully incorporated by reference:

U.S. Pat. No. 4,950,227 issued Aug. 21, 1990 to Savin et al. entitled“STENT DELIVERY SYSTEM” and assigned to Boston Scientific Corporation.

REFERENCE TO CO-PENDING APPLICATIONS

Reference is hereby made to the following co-pending U.S. patentapplications:

U.S. patent application Ser. No. 09/035,652, filed Mar. 5, 1998,entitled “DILATATION AND STENT DELIVERY SYSTEM FOR BIFURCATION LESIONS”;

U.S. patent application Ser. No. 09/028,792, filed Feb. 24, 1998,entitled “STENTS AND STENT DELIVERY AND DILATATION SYSTEM FORBIFURCATION LESIONS”;

U.S. patent application Ser. No. 09/129,472, filed Aug. 4, 1998,entitled “SYSTEM FOR DELIVERING STENTS TO BIFURCATION LESIONS”; and

U.S. patent application Ser. No. 09/148,179, filed Sep. 4, 1998,entitled “SYSTEM FOR DELIVERING BIFURCATION STENTS”.

BACKGROUND OF THE INVENTION

The present invention relates to a system for treating vascular disease.More specifically, the present invention relates to a system fordeploying a stent in a bifurcation lesion.

Vascular disease currently represents a prevalent medical condition.Typical vascular disease involves the development of a stenosis in thevasculature. The particular vessel containing the stenosis can becompletely blocked (or occluded) or it can simply be narrowed (orrestricted). In either case, restriction of the vessel caused by thestenotic lesion results in many well known problems caused by thereduction or cessation of blood circulation through the restrictedvessel.

A bifurcation is an area of the vasculature where a first (or parent)vessel is bifurcated into two or more branch vessels. It is not uncommonfor stenotic lesions to form in such bifurcations. The stenotic lesionscan affect only one of the vessels (i.e., either of the branch vesselsor the parent vessel) two of the vessels, or all three vessels.

Vascular stents are also currently well known. Vascular stents typicallyinvolve a tubular stent which is movable from a collapsed, low profile,delivery position to an expanded, deployed position. The stent istypically delivered using a stent delivery device, such as a stentdelivery catheter. In one common technique, the stent is crimped down toits delivery position over an expandable element, such as a stentdeployment balloon. The stent is then advanced using the catheterattached to the stent deployment balloon to the lesion site under anysuitable, commonly known visualization technique. The balloon is thenexpanded to drive the stent from its delivery position to its deployedposition in which the outer periphery of the stent frictionally engagesthe inner periphery of the lumen. In some instances, the lumen ispredilated using a conventional dilatation catheter, and then the stentis deployed to maintain the vessel in an unoccluded, and unrestrictedposition.

Self-expanding stents can also be used. Self-expanding stents aretypically formed of a resilient material. The resilient material hassufficient resilience that it can be collapsed to the low profileposition and inserted within a delivery device, such as a catheter. Oncethe catheter is placed at the site of the stenotic lesion, the stent ispushed from within the catheter such that it is no longer constrained inits low profile position. The stent, driven by the resilience of thematerial, expands to a higher profile, deployed position in which itsouter periphery frictionally engages the walls of the stenosed vessel,thereby reducing the restriction in the vessel.

While there have recently been considerable advances in stent design andstent deployment techniques, current methods of treating bifurcationlesions are suboptimal, particularly where both downstream branchvessels are affected by the lesion. Current techniques of dealing withsuch lesions typically require the deployment of a slotted tube stentacross the bifurcation. However, this compromises the ostium of theunstented branch.

Further, once the first stent is deployed, the treating physician mustthen advance a dilatation balloon between the struts of the stentalready deployed in order to dilate the second branch vessel. Thephysician may then attempt to maneuver a second stent through the strutsof the stent already deployed, into the second branch vessel fordeployment. This presents significant difficulties. For example,dilating between the struts of the stent already deployed tends todistort that stent. Further, deploying the second stent through thestruts of the first stent is not only difficult, but it can also distortthe first stent. Thus, the current systems used to alternately deploystents in a bifurcated lesion have significant disadvantages.

Also, since two guidewires are often used to deploy stents at abifurcation, the guidewires can become crossed, or somewhat entangled.The deployment systems which are advanced along such guidewires canbecome caught on the wires, where they cross over one another. This canrequire additional time and manipulation of the stent deployment systemin order to properly deploy the stent at the bifurcation.

Further, some branch vessels can have somewhat smaller diameter lumensthan the parent vessels from which they branch. Therefore, stents ofdifferent sizes need to be deployed in the parent vessel and the branchvessel. Alternatively, a single stent having a larger diameter portion,and one or more smaller diameter portions, can be deployed at thebifurcation. However, this can lead to difficulty in deployment. Forinstance, a balloon which is sized to fit within the smaller diameterstent portion, and deploy that portion, may not be large enough todeploy the larger diameter stent portion. Therefore, a plurality ofballoon catheters must be used to deploy such stents.

SUMMARY OF THE INVENTION

The present invention is drawn to a system for deploying a stent at abifurcation. In one embodiment, the system includes a stepped balloonwhich has a first section of a first diameter, and a second section of asecond diameter. The first portion is sized to deploy a first stentportion, having a larger deployed diameter, while the second portion issized to deploy a second stent portion, having a smaller deployeddiameter.

Other embodiments of the present invention include a dual balloon stentdeployment catheter, a distal sleeve covering the distal portion of thestent during deployment, and a number of mechanisms for stiffening andtorquing the stent deployment device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a typical bifurcation lesion.

FIGS. 2 and 3 illustrate a stent having two different deployeddiameters.

FIG. 4 illustrates the stent shown in FIGS. 2 and 3 deployed in abifurcation.

FIG. 5 illustrates a dual-balloon stent deployment system.

FIGS. 6A and 6B illustrate deployment of the stent deployment systemillustrated in FIG. 5.

FIG. 7 illustrates another embodiment of a dual-balloon stent deploymentsystem.

FIGS. 8A and 8B illustrate catching of a distal portion of a stentdeployment system on crossed or tangled guidewires.

FIGS. 9A-9C illustrate a stent deployment system with a distal sleevedisposed thereabout.

FIG. 10 illustrates another embodiment of a dual-balloon stentdeployment system.

FIGS. 10A-10C illustrate another embodiment of a dual-balloon stentdeployment system.

FIGS. 11A and 11B illustrate another embodiment of a dual-balloon stentdeployment system.

FIGS. 12A-12C illustrate a stepped-balloon stent deployment system.

FIGS. 13A-13C illustrate a retractable stent deployment system.

FIGS. 14A-14C illustrate a collapsible embodiment of a stepped balloonstent deployment system.

FIGS. 15A-15C illustrate stiffening and torquing systems for use with astent deployment system.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 illustrates bifurcation 10 which includes parent vessel 12, firstbranch vessel 14 and second branch vessel 16. FIG. 1 also illustratesthat a bifurcation lesion 18 has developed in bifurcation 10. Asillustrated, lesion 18 extends into both branch vessels 14 and 16, andextends slightly into parent vessel 12 as well. Lesion 18 may also belocated on only one side of the branch vessel 14 or 16. In either case,it is preferable to stent both branch vessels 14 and 16 to avoidcollapsing one. In order to treat bifurcation lesion 18, it may commonlyfirst be predilated with a conventional angioplasty balloon catheterdilatation device.

FIG. 2 is a side view of a stent 20 which can be used to treat a portionof bifurcation 10. Stent 20 includes a first portion 22 and a secondportion 24. First portion 22 has a relatively large deployed diameter,while second portion 24 has a somewhat smaller deployed diameter.

FIG. 3 is an end view of stent 20 taken as indicated by arrows 3-3 inFIG. 2. In one illustrative embodiment, portions 22 and 24 of stent 20are simply discrete stents which have been interwoven, or attached, toone another. Alternatively, stent 20 can be formed by one integral stentformed with portions 22 and 24 being integral with one another. Ineither case, stent 20 can preferably be deformed to a low profile,collapsed (or deployment) position in which it can be inserted throughparent vessel 12 to bifurcation 10. Stent 20 is then deployed, eitherusing its own resilience, or using a balloon deployment system, to itsexpanded, deployed position illustrated in FIG. 2.

FIG. 4 illustrates stent 20 deployed in bifurcation 10. In FIG. 4, firstand second guidewires 26 and 28 are first inserted, through parentvessel 12, to bifurcation 10 such that guidewire 26 has a distal endresiding in branch vessel 14 while guidewire 28 has a distal endresiding in branch vessel 16. Using a stent deployment system, such asany of those described in greater detail later in the specification,stent 20 is advanced in a low profile, insertion position to thelocation illustrated in FIG. 4. Stent 20 is then deployed by expandingportions 22 and 24 to the deployed positions illustrated in FIG. 4. Inone illustrative embodiment, portion 24 has an outer diameter which,when deployed, frictionally engages the inner diameter of branch vessel14. Similarly, portion 22 has an outer diameter which, when deployed, issufficient to frictionally engage the inner diameter of parent vessel12, to remain in place in bifurcation 10.

FIG. 5 is a side view of a dual-balloon stent deployment system 30 inaccordance with one aspect of the present invention. System 30 is shownwith a cross-section of stent 20, in the deployed position, disposedthereon. System 30 includes a proximal catheter 32 having a lumen 34disposed therein. First and second guidewire lumens (or tubes) 36 and 38extend from within lumen 34 and extend to distal ends 40 and 42. System30 also includes a first, proximal balloon 44 and a second, distalballoon 46. Balloon 44 has a proximal end 48 which is sealed to thedistal end of catheter 32. While proximal end 48 of balloon 44 can besealed to either the outer or inner side of catheter 32, it isillustrated in FIG. 5 as being sealed to the outer surface of catheter32, using, for example, an adhesive. Balloon 44 also has a distal end 50which is sealed, with a fluid tight seal, about guidewire tube 36 and aportion of the proximal end 52 of balloon 46.

Balloon 46 includes a proximal end 52 which is also fluidly sealedpartially to an inside surface or the distal waist of balloon 44 andpartially to guidewire lumen 38. However, an inflation lumen 54 extendsfrom the interior of balloon 44, through the proximal end 52 of balloon46, and communicates with the interior or balloon 46. Balloon 46 furtherincludes a distal end 56 which is sealed to the outer surface ofguidewire lumen 42. Therefore, an inflation lumen for inflating balloons44 and 46 is defined by lumen 34 of catheter 42, and lumen 54 disposedabout at least a portion of guidewire tubes 36 and 38.

Guidewire lumen 38 extends from lumen 34 distally through both balloons44 and 46, and protrudes out the distal end 56 of balloon 46. Guidewirelumen 36, on the other hand (and as will be disclosed in greater detaillater in the specification) is used to track a guidewire which extendsdown a branching vessel. Guidewire lumen 38 has a distal end 40 whichextends out from within the distal end 50 of balloon 44, and extends toa position outside of balloon 46. Both balloons 44 and 46 can preferablybe collapsed to a low profile, insertion position. However, balloon 44has a relatively large inflated diameter for driving deployment of thelarger diameter portion 22 of stent 20. Balloon 46, on the other hand,has a smaller inflated diameter for driving deployment of the smallerdiameter stent portion 24 of stent 20.

FIGS. 6A and 6B illustrate the deployment of stent 20 utilizing system30 illustrated in FIG. 5. FIG. 6A illustrates system 30 in the insertionposition. First, guidewires 26 and 28 are advanced through thevasculature to bifurcation 10, such that they reside within branchvessels 14 and 16, respectively. It should be noted that system 30 canbe backloaded onto guidewires 26 and 28. In that case, prior toinserting guidewires 26 and 28, system 30 is loaded onto the guidewiresuch that guidewire 26 resides within guidewire tube 38 while guidewire28 resides within tube 30. Alternatively, system 30 can be loaded ontoguidewires 26 and 28 from the proximal end of the guidewires. In eithercase, after the guidewires are positioned appropriately, system 30 isadvanced using catheter 32 through the vasculature (and may be advancedthrough a guide catheter 58) to bifurcation 10. System 30 is thenfurther advanced such that stent portion 24 follows guidewire 26 andresides within branch vessel 14.

Once in the position illustrated in FIG. 6A, fluid is introduced intoballoons 44 and 46 through catheter 32, to inflate the balloons. Thisdrives stent portions 22 and 24 of stent 20 into the deployed positionillustrated in FIG. 6B. In the deployed position, the outer diameter ofstent portions 22 and 24 are sufficient to frictionally engage theinterior vessel walls of parent vessel 12 and branch vessel 14,respectively, such that stent 20 is frictionally held in place inbifurcation 10. The lumens 44 and 46 are then deflated, and system 30 isremoved from within stent 20. Guidewires 26 and 28 are then removed frombifurcation 10, leaving stent 20 deployed in place.

System 30 preferably employs balloons 44 and 46 which have steepproximal and distal cone angles in order to reduce any gap between theballoons. this increases the ability to exert adequate deployment forceon stent portions 22 and 24. Similarly, post delivery dilatation may beused in order to further dilate the lesion from within the deployedstent 20.

FIG. 7 illustrates a side view of another embodiment of a dual-balloonstent deployment system 60 in accordance with one aspect of the presentinvention. System 60 has a number of items which are similar to system30 shown in FIG. 5, and those items are similarly numbered in FIG. 7.System 60 includes a proximal balloon 62 which has a proximal end 64 anda distal end 66. The proximal end 64 in balloon 62 is sealed about thedistal end of catheter 32. The interior of balloon 62 communicates withlumen 34 of catheter 32. The distal end 66 of balloon 62 is formed in acone configuration. A radially interior portion is sealed aboutguidewire tubes 36 and 38, leaving an inflation lumen 68 therebetween,which communicates with the interior of balloon 46. The radial outwardportion of the distal end 66 of balloon 62, when inflated, assumes anouter diameter which is substantially the same as the maximum diameterof the remainder of balloon 62. However, the distal end 66 is formed ina reverse cone shape such that the radial outward portion of the distalend 66 is substantially tubular in shape. The balloon tapers proximallyalong a portion 70 to the inner diameter portion of balloon 62.

In this way, the outer diameter of balloon 62 obtains a substantiallygreater size, at its extreme distal end, than balloon 44 in system 30.This assists in deploying portion 22 of stent 20. Again, post-deliverydilatation may be used to further advance stent portions 22 and 24toward the wall of vessels 12 and 14, respectively. Stent deploymentsystem 60 is deployed in a similar fashion as stent deployment system30, illustrated with respect to FIGS. 6A and 6B.

FIGS. 8A and 8B illustrate a problem which can be encountered indeploying a stent in a bifurcation. FIG. 8A illustrates a stentdeployment system 72 located just proximally of bifurcation 10. Stentdeployment system 72 includes a distal stent portion 74 which has adistal end 76. FIG. 8A also illustrates that guidewires 26 and 28 arecrossed over one another in a cross-over region 78. As deployment system72 is advanced distally, the distal end 76 of stent portion 74encounters cross over region 78. FIG. 8B illustrates that the distal end76 of stent portion 74 can actually catch, and hang up on, a portion ofguidewire 28 which is crossed over guidewire 26. This makes it verydifficult, if not impossible, to continue to advance stent deploymentsystem 72 distally over guidewires 26 and 28. Instead, system 72 must bewithdrawn proximally, and the guidewires 26 and 28 must be remanipulatedor deployment system 72 must be torqued (rotated about its longitudinalaxis) or otherwise maneuvered, in an attempt to loosen guidewire 28 fromthe distal end 76 of stent portion 74.

FIG. 9A illustrates stent deployment system 60, as discussed withrespect to FIG. 7, but with the addition of a distal sleeve 80 or aproximal sleeve 82 or both disposed about the distal end of stentportion 24 and the proximal end of stent portion 22, respectively.Distal sleeve 80 and proximal sleeve 82 are provided in order tominimize the likelihood that the longitudinal ends of stent 20 willcatch or engage any unwanted obstacles, such as tissue or guidewires.The sleeves 80 and 82 are described in greater detail in U.S. Pat. No.4,950,227, which is fully incorporated herein by reference. Briefly,sleeves 80 and 82 are illustratively formed of silicone and areapproximately 2 cm in length. Sleeve 80 is fixed to the distal end 42 ofguidewire lumen 38 using adhesive or welding. Similarly, the proximalend of sleeve 82 is fixed to the distal end of catheter 32, using asuitable adhesive. Such adhesive may, for example, be comprised of aurethane bead. Sleeves 80 and 82 overlap stent portions 24 and 22,respectively, by a distance which is approximately 3 mm. Further, in oneembodiment, sleeves 80 and 82 have tapered distal edges. In a furtherembodiment, sleeves 80 and 82 have tapered distal and proximal edges.This facilitates the transfer of system 60 within the vasculature, whiledecreasing the tendency to catch or engage undesired obstacles.

FIGS. 9B and 9C illustrate the deployment of stent portion 24 and theinteraction of stent portion 24 with sleeve 80. A similar interaction isobtained between sleeve 82 and the proximal end of stent portion 22. Asstent portion 24 is deployed, balloon 46 is inflated and the distal endof stent portion 24 is released from within sleeve 80. This isillustrated in FIG. 9B. Then, after stent portion 24 is deployed andballoon 46 is deflated (and thus radially retracted) sleeve 80 contractsabout the distal end of balloon 46. The deflation of balloon 46facilitates removal of balloon 46, as well as sleeve 80, from within thedeployed stent portion 24, as deployment system 60 is axially removedfrom the vasculature. It should be noted that sleeves 80 and 82 can beused on substantially any of the embodiments described herein.

FIG. 10 illustrates another dual-balloon stent deployment system 90 inaccordance with one aspect of the present invention. System 90 includesan outer sheath 92, an inner sheath 94 defining an inflation lumen 96, aplurality of guidewire lumens 98 and 100, each having distal ends 102and 104, respectively. System 90 also includes first balloon 106 andsecond balloon 108. First balloon 106 has a distal end 110 which issealed about the outer surface of guidewire lumen 102. Balloon 106 alsohas a proximal end 112 which is sealed within a disc 114 which is sealed(such as through adhesive) to the inside of the distal end of catheter94. Balloon 108 has a distal end 116 which is sealed about the outersurface of guidewire lumen 104, and a proximal end 118 which is sealedwithin disc 114. The interior of balloons 106 and 108 are in fluidcommunication with the lumen 96 formed by inner catheter 94. Thisprovides an arrangement to provide fluid under pressure to inflateballoons 106 and 108. It should be noted that, instead of using disc114, the inside of the distal end of catheter 94 can simply be filledwith adhesive using a technique commonly referred to as potting.

Balloons 106 and 108 can either have the same, or different, deployeddiameters. However, balloon 108 may have a greater longitudinal lengththan balloon 106. Therefore, stent portion 22 of stent 20 can bedeployed by inflating both balloons 106 and 108 to drive stent portion22 into its higher profile, deployed position. By contrast, stentportion 24 is disposed only about the distal part of balloon 108, distalof balloon 106. Thus, stent portion 24 is deployed by the inflation ofballoon 108. System 90 is used to deploy stent 20 in a similar fashionto that described with respect to system 30 in FIGS. 6A and 6B.

FIGS. 10A-10C illustrate another stent deployment system 120. System 120is similar to system 90 illustrated in FIG. 10, and similar items aresimilarly numbered. However, rather than having a disc 114 disposed atthe distal end of catheter 94, system 120 has a plug member 122 (whichis also illustrated in FIGS. 10B and 10C). Plug member 122 has anexterior surface which snugly fits within the interior of the distal endof catheter 94, and is secured therein, such as by frictional fit orsuitable adhesive. Plug member 122 also has generally tubular extensions124 and 126 which extend from a body 128 thereof. A pair of lumens 130and 132 extend through body 128 and through extension members 124 and126, respectively. Lumens 130 and 132 are larger than guidewire lumens98 and 100 such that guidewire lumens 98 and 100 can pass therethrough,and still leave an area which provides fluid communication between lumen96 of catheter 94 and the interior of balloons 106 and 108,respectively. This provides a mechanism by which balloons 106 and 108can be inflated through the infusion of pressurized fluid through lumen96 in catheter 94.

In addition, the proximal ends 112 and 118 of balloons 106 and 108 areillustratively fastened about the exterior of extension members 124 and126, respectively. Such fastening can take any suitable form, such asthrough adhesive.

FIGS. 11A and 11B illustrate yet another embodiment of a stentdeployment system 138 in accordance with another aspect of the presentinvention. System 138 includes a first balloon 140 and a second balloon142. Each balloon is disposed about a guidewire lumen 144 and 146,respectively. A proximal catheter 148 is provided with two separateinflation lumens 150 and 152. Inflation lumen 150 is provided to inflateballoon 140 while inflation lumen 152 is provided to inflate balloon142. The proximal end of balloons 140 and 142 are sealably connectedabout inflation lumens 150 and 152 and guidewire lumens 144 and 146.

Similarly, catheter 148 is also provided with a stiffening member 154.Stiffening member 154 is preferably a stiffening wire (or a pair ofstiffening wires or a hypotube) which runs at least through a distalportion of catheter 148, and is fastened thereto, to provide increasedpushability, and increased torquability.

FIG. 11B is a cross-sectional view of catheter 148 taken along sectionlines 11B-11B shown in FIG. 11A. FIG. 11B shows that, in oneillustrative embodiment, catheter 148 includes a pair of stiffeningmembers 154A and 154B which are either embedded within, or fixedlysecured to, the wall of catheter 148. Similarly, FIG. 11B betterillustrates that inflation lumens 150 and 152 are generallykidney-shaped (or shaped in a generally hemispherical shape) and extendpartially about the guidewire lumens 144 and 146, respectively. System138 is used to deploy stent 20 in a fashion similar to system 30illustrated in FIGS. 6A and 6B.

FIG. 12A is a side view of another embodiment of a stent deploymentsystem 160 in accordance with one aspect of the present invention.System 160 includes a catheter 162 with a lumen 164 therein. A guidewirelumen 166 extends through lumen 164 to a distal end 168 of the guidewirelumen. System 160 also includes a stepped balloon 170. Stepped balloon170 has a distal end 172 sealably connected about the outer surface ofguidewire lumen 168. Balloon 170 also has a proximal end 174 sealablyconnected about the external surface of catheter 162. In addition,balloon 170 has a first portion 176 which has a first inflated outerdiameter and a second portion 178 which has a second inflated outerdiameter, less than the first inflated outer diameter of portion 176.Balloon 170 has a step region 180 which defines the transition betweenportion 176 and 178. The step region 180, in the embodiment illustratedin FIG. 12A, is simply a steeply tapering portion which extends from theinflated outer diameter of balloon portion 178 to the inflated outerdiameter of balloon portion 176. Balloon 170 is preferably formed of aconventional balloon material preformed into the stepped shapeillustrated generally in FIG. 12A.

Thus, stent 20 can be deployed using only a single balloon 170. Thesmaller diameter stent portion 24 is disposed over balloon portion 178,while the larger diameter balloon stent portion 22 is disposed overballoon portion 176.

FIG. 12B illustrates another stepped balloon 182. Balloon 182 alsoincludes first and second portions 184 and 186. However, the step inballoon 182 is generally concentric, rather than eccentric as describedwith respect to FIG. 12A. FIG. 12C illustrates balloon 182 disposedwithin bifurcation 10. In one illustrative embodiment, stent 20 hassection 22, which is weaker than section 24. Due to the strength ofstent 20, the step in balloon 182 moves or shifts from being concentric,to being non-concentric, as illustrated in FIG. 12C. The eccentricityshifts towards the open cell (or weaker section) of stent 22.

FIGS. 13A-13C illustrate another stent deployment system 190 inaccordance with one aspect of the present invention. Deployment system190 includes stepped balloon 182 with a guidewire lumen 192 extendingtherethrough. Stent 20 is disposed about balloon 182. In addition,within stent portion 22, and on the exterior of balloon 182, is provideda second guidewire lumen 194. A proximal catheter 196 is coupled tofluidly communicate with the interior of balloon 182. A pull wire 198 iscoupled to the proximal end of guidewire lumen 194 and to a pull sleeve200 slidably disposed about catheter 196, generally at the proximal endof catheter 196.

FIGS. 13A and 13B illustrate the insertion of system 190 for deploymentof stent 20. FIG. 13B illustrates that system 190 is advanced throughthe vasculature over guidewires 26 and 28 such that the distal end ofballoon 182 (and stent portion 24) resides within branch vessel 14.Stent 20 is deployed under relatively low pressure to pre-dilate thestent. Next, guidewire lumen 194 is withdrawn proximally in thedirection indicated by arrow 202, by user withdrawal of sleeve 20proximally over catheter 196.

Balloon 182 is then further inflated to a relatively high pressure topost-dilate the stent, as illustrated in FIG. 13C. This acts to deploystent 20 outwardly causing the outer surface of stent 20 to frictionallyengage the interior surface of parent vessel 12 in branch vessel 14.Balloon 182 is then deflated and the system is withdrawn from thevasculature, leaving stent 20 in place in bifurcation 10.

FIGS. 14A-14C illustrate another stent deployment system 210 inaccordance with one aspect of the present invention. System 210 issimilar to system 190 described with respect to FIGS. 13A-13C, andsimilar items are similarly numbered. However, system 210 allowsguidewire lumen 194 to remain in place, adjacent balloon 182, duringdeployment of stent 20. Therefore, rather than having a removableguidewire lumen 194, system 210 includes guidewire lumen 212. As insystem 190, guidewire lumen 212 resides within portion 22 of stent 20,but on the exterior of balloon 182.

FIG. 14B illustrates that system 210 is inserted within bifurcation 10in a manner similar to system 190 (illustrated in FIG. 13B). However,guidewire lumen 212 remains in place during inflation of balloon 182, asshown in FIG. 14C. In one preferred embodiment, at least the distalportion 214 of guidewire lumen 212 is collapsible. Therefore, as balloon182 is inflated, the distal portion 214 (which resides within stent 20)of guidewire lumen 212 collapses against the inner wall of stent portion22, about guidewire 28. The exterior periphery of balloon 182 drivesdeployment of stent portion 22, by exerting pressure on the collapsibleportion 214 of guidewire lumen 212.

In another embodiment, the distal portion 214 of guidewire tube 212 issubstantially rigid. When balloon 182 is inflated, tube 212 stays inplace. Therefore, inflation of balloon 182 exerts pressure on tube 212causing stent portion 22 to deploy radially outwardly.

FIGS. 15A-15C illustrate another embodiment of the present invention.For purposes of the present discussion, system 210 illustrated withrespect to FIGS. 14A-14C is illustrated in FIG. 15A, along with atorquing system 220. However, it will be appreciated that torquingsystem 220 can be used with substantially any of the other embodimentsdiscussed herein.

Torquing system 220 includes a shaft 222 disposed about guidewire lumen212 and catheter 196. System 220 also includes a slidable sleeve 224which is slidably engageable with the exterior surface of shaft 222.Sleeve 224 is preferably substantially rigid when compared with, forexample, catheter 196. When sleeve 224 slidably engages the surface ofshaft 222, the user can torque or rotate sleeve 222 and thussubstantially increase the torquability (or rotatability) of stentdeployment system 210.

FIG. 15B is a rear perspective view of one embodiment of shaft 222 andsleeve 224. In one embodiment, shaft 222 is a relatively flexible andresilient shaft, made of suitable polymer material which is commerciallyavailable and conventionally used to make percutaneous catheters.However, shaft 222 includes flattened wall surfaces 226 disposed ongenerally opposite sides thereof. Sleeve 224 is either a full hypotube,or a portion thereof, which also has flattened sides 228 which arespaced from one another just far enough to slidably receive theflattened surfaces 226 of shaft 222. Therefore, when the user advancessleeve 224 distally such that the sides 228 engage surfaces 226, theuser can more easily torque system 210.

FIG. 15C illustrates an alternative embodiment of shaft 222 and sleeve224. In the embodiment illustrated in FIG. 15C, shaft 222 has one ormore slots 230 defined about the perimeter thereof. Similarly, sleeve224 has corresponding radially inwardly directed protrusions 232disposed thereabout. Protrusions 232 are sized just smaller than slots230. Therefore, as the user slides sleeve 224 distally, protrusions 232slidably engage, and slide within, slots 230. Since sleeve 224 is madeof a relatively rigid material, it can be used to torque, or steer,system 210 within the vasculature.

Thus, it can be seen that the present invention provides a system fordeploying a stent at a bifurcation. The system includes a variety ofdual-balloon delivery and deployment systems. In another embodiment, thesystem includes a stepped balloon arrangement. Further, in anotherembodiment, the system includes a mechanism by which torquability can beincreased to make positioning of the stent delivery system within thevasculature much easier.

Although the present invention has been described with reference topreferred embodiments, workers skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention.

1-24. (canceled)
 25. A balloon catheter for use in treating a vascularbifurcation, comprising: (a) a catheter shaft having a distal endportion; and (b) a stepped balloon positioned at the distal end portionof the catheter shaft, the stepped balloon including; (i) a proximalportion having an outer surface that defines a first average diameter,the proximal portion defining a proximal end portion of the steppedballoon, the proximal portion configured for placement at a proximalportion of the vascular bifurcation; (ii) a distal portion having anouter surface that defines a second average diameter, the second averagediameter being smaller than the first average diameter, the distalportion defining a distal end portion of the stepped balloon, the distalportion configured for placement at a distal portion of the vascularbifurcation; and (iii) a transition portion extending between the firstand second portions.
 26. The balloon catheter of claim 25, wherein thesecond average diameter is at least one half the value of the firstaverage diameter.
 27. The balloon catheter of claim 25, wherein theproximal and distal portions are concentric.
 28. The balloon catheter ofclaim 25, wherein the first average diameter is substantially the samealong an entire length of the first portion.
 29. The balloon catheter ofclaim 25, wherein the second average diameter is substantially the samealong an entire length of the second portion.
 30. The balloon catheterof claim 25, wherein at least a portion of the first portion is tapered.31. The balloon catheter of claim 35, wherein at least a portion of thesecond portion is tapered.
 32. The balloon catheter of claim 25, whereinthe balloon catheter is configured for use with a stent for a stentdelivery application.
 33. The balloon catheter of claim 25, wherein thefirst section has a larger length than a length of the second section.34. The balloon catheter of claim 25, wherein a length of the secondportion is greater than a length of the first portion.
 35. The ballooncatheter of claim 25, wherein the lengths of the first and secondportions are about the same.
 36. A balloon catheter assembly for use ina vascular anatomy, the assembly comprising: (a) a catheter shaft havinga distal end portion and defining an inflation lumen; and (b) a balloonextending from the distal end portion of the catheter shaft, the balloonhaving a shaped outer geometry that includes: (i) a first portion havinga first diameter, the first portion defining a proximal end portion ofthe balloon; and (ii) a second portion having a second diameter that isless than the first diameter, the second portion defining a distal endportion of the balloon.
 37. The balloon catheter of claim 36, whereinthe second average diameter is at least one half the value of the firstaverage diameter.
 38. The balloon catheter of claim 36, wherein theproximal and distal portions are concentric.
 39. The balloon catheter ofclaim 36, wherein the shaped outer geometry of the balloon furtherincludes a transition portion extending between the first and secondportion of the balloon, the transition portion defining a taperedsurface that extends non-parallel with each of the first and secondportions.
 40. The balloon catheter of claim 36, further comprising aguidewire member defining a guidewire lumen, the guidewire memberextending through a portion of the catheter shaft and distally beyondthe distal end portion of the catheter shaft, a distal end portion ofthe balloon mounted to a distal end portion of the guidewire.
 41. Theballoon catheter of claim 36, further comprising a stent, the stenthaving opposing distal and proximal open ends, the balloon extendingthrough the stent between the distal and proximal open ends.
 42. Theballoon catheter of claim 36, wherein the balloon further includes atransition portion, the transition portion extending between the firstand second portions of the balloon.
 43. A method of treating a vascularbifurcation or side-branch anatomy with a balloon catheter, the ballooncatheter including a balloon having a first balloon portion, a secondballoon portion, and a transition portion, the first and second balloonportions having different outer diameters, the method comprising:mounting a stent in a unexpanded state on an exterior of the balloon;positioning the balloon with the stent in a unexpanded state at avascular bifurcation with the first balloon portion extending proximalof the vascular bifurcation and the distal balloon portion extendingdistal of the vascular bifurcation; inflating the balloon to expand thestent into an expanded state at the vascular bifurcation; and removingthe balloon catheter from the vascular bifurcation.
 44. The method ofclaim 43, wherein the step of positioning the balloon includes aligningthe transition portion of the balloon with features of the vascularbifurcation prior to inflating the balloon.
 45. A catheter balloon,comprising: (a) a proximal portion having an outer surface that definesa first average diameter, the proximal portion defining a proximal endportion of the stepped balloon, the proximal portion configured forplacement at a proximal portion of the vascular bifurcation; (b) adistal portion having an outer surface that defines a second averagediameter, the second average diameter being smaller than the firstaverage diameter, the distal portion defining a distal end portion ofthe stepped balloon, the distal portion configured for placement at adistal portion of the vascular bifurcation; and (c) a transition portionthat extends from the proximal portion to the distal portion.
 46. Thecatheter balloon of claim 45, wherein the balloon is configured for usewith a stent that is expanded upon inflation of the balloon.
 47. Thecatheter balloon of claim 45, wherein the first section has a greaterlength than a length of the second section.
 48. The catheter balloon ofclaim 45, wherein a length of the second portion is greater than alength of the first portion.
 49. The catheter balloon of claim 45,wherein the lengths of the first and second portions are about the same.50. A balloon catheter for use in a vascular bifurcation or side-branchanatomy, comprising: a catheter body; and a balloon positioned at adistal portion of the catheter body, the balloon including a balloonouter skin, a first lumen adapted to receive a guidewire and a secondlumen configured to provide inflation and deflation of the balloon, theballoon having a first section with a first average diameter, and secondsection with a second average diameter that is smaller than the firstaverage diameter, the first and second sections being coupled by atransition section that has a geometry and is sized to reduce vesseldamage when position at a point of vessel bifurcation.
 51. The catheterof claim 50, further comprising: a radiopaque marker positioned at theballoon.
 52. The catheter of claim 51, wherein the radiopaque marker ispositioned at the transaction section.
 53. The catheter of claim 51,wherein the radiopaque marker is positioned at a location that providesan indication of a bifurcation or side-branch position in a vascularanatomy.
 54. The balloon catheter of claim 50, wherein the balloon ismade of any suitable polymer, non-polymer or composite material thereof.55. The balloon catheter of claim 50, wherein the first average diameteris substantially the same along an entire length of the first section.56. The balloon catheter of claim 50, wherein the second averagediameter is substantially the same along an entire length of the secondsection.
 57. The balloon catheter of claim 50, wherein the second lumenincludes an inflation and deflation aperture positioned in the firstsection.
 58. The balloon catheter of claim 50, wherein the second lumenincludes an inflation and deflation aperture positioned in the firstsection.
 59. The balloon catheter of claim 50, wherein at least aportion of the first section is tapered.
 60. The balloon catheter ofclaim 50, wherein at least a portion of the second section is tapered.61. The balloon catheter of claim 50, wherein a radiopaque marker ispositioned at a proximal section of the balloon.
 62. The ballooncatheter of claim 50, wherein a radiopaque marker is positioned at adistal portion of the balloon.
 63. The balloon catheter of claim 50,wherein the catheter body is part of an over-the-wire catheter system.64. The balloon catheter of claim 50, wherein the catheter body is partof a rapid-exchange catheter system.
 65. The balloon catheter of claim50, wherein the balloon catheter is configure for use in an angioplastyapplication in a vessel with a stenting procedure.
 66. The ballooncatheter of claim 50, wherein the balloon catheter is configure for usein an angioplasty application in a vessel without a stenting procedure.67. The balloon catheter of claim 50, wherein the balloon catheter isconfigured for use with a stent for a stent delivery application. 68.The balloon catheter of claim 50, wherein the balloon catheter is usedas a stent delivery system with a stent designed for a bifurcation orside branch vascular anatomy.
 69. The balloon catheter of claim 50,wherein the first section has a larger length than a length of thesecond section.
 70. The balloon catheter of claim 50, wherein a lengthof the second is greater than a length of the first section.
 71. Theballoon catheter of claim 50, wherein the lengths of the first andsecond sections are about the same.
 72. An angioplasty balloon catheterfor use in a vascular anatomy, comprising: an angioplasty catheter body;and a tubular balloon coupled to a distal end of the angioplastycatheter body and including, a shaped balloon skin, a catheter shaftwith a first lumen configured to receive a guidewire and a second lumenconfigured to be provide inflation-deflation of the balloon, the balloonhaving a shaped outer geometry and size to reduce vessel damage whenposition at a point of vessel bifurcation.
 73. The balloon catheter ofclaim 72, further comprising: a radiopaque marker positioned at thetubular balloon.
 74. The catheter of claim 73, wherein the radiopaquemarker is positioned at a location that provides an indication of abifurcation or side-branch position in a vascular anatomy.
 75. Theballoon catheter of claim 72, wherein the balloon is made of anysuitable polymer, non-polymer or composite material thereof.
 76. Theballoon catheter of claim 72, wherein the balloon includes a firstsection with a first average diameter, and a second section with asecond average diameter.
 77. The balloon catheter of claim 76, whereinthe first average diameter is substantially the same along an entirelength of the first section.
 78. The balloon catheter of claim 76,wherein the second average diameter is substantially the same along anentire length of the second section.
 79. The balloon catheter of claim76, wherein the second lumen includes an inflation and deflationaperture positioned in the first section.
 80. The balloon catheter ofclaim 76, wherein the second lumen includes an inflation and deflationaperture positioned in the first section.
 81. The balloon catheter ofclaim 76, wherein at least a portion of the first section is tapered.82. The balloon catheter of claim 76, wherein at least a portion of thesecond section is tapered.
 83. The balloon catheter of claim 72, whereina radiopaque marker is positioned at a proximal section of the balloon.84. The balloon catheter of claim 72, wherein a radiopaque marker ispositioned at a distal portion of the balloon.
 85. The balloon catheterof claim 72, wherein the catheter body is part of an over-the-wirecatheter system.
 86. The balloon catheter of claim 72, wherein thecatheter body is part of a rapid-exchange catheter system.
 87. Theballoon catheter of claim 72, wherein the balloon catheter is configurefor use in an angioplasty application in a vessel with a stentingprocedure.
 88. The balloon catheter of claim 72, wherein the ballooncatheter is configure for use in an angioplasty application in a vesselwithout a stenting procedure.
 89. The balloon catheter of claim 72,wherein the balloon catheter is configured for use with a stent for astent delivery application.
 90. The balloon catheter of claim 72,wherein the balloon catheter is used as a stent delivery system with astent designed for a bifurcation or side branch vascular anatomy. 91.The balloon catheter of claim 76, wherein the first section has a largerlength than a length of the second section.
 92. The balloon catheter ofclaim 76, wherein a length of the second is greater than a length of thefirst section.
 93. The balloon catheter of claim 76, wherein the lengthsof the first and second sections are about the same.
 94. A stentdelivery device, comprising: a catheter body; a balloon positioned at adistal portion of the catheter body, the balloon including a balloonouter skin, a first lumen adapted to receive a guidewire and a secondlumen configure to provide inflation and deflation of the balloon, theballoon having a first section with a first average diameter, and secondsection with a second average diameter that is smaller than the firstaverage diameter, the first and second sections being coupled by atransition section that has a geometry and is sized to reduce vesseldamage when position at a point of vessel bifurcation; and a vascularstent positioned on an exterior of the balloon exterior.
 95. The deviceof claim 94, further comprising: a radiopaque marker positioned at theballoon.
 96. The device of claim 95, wherein the radiopaque marker ispositioned at the transaction section.
 97. The device of claim 95,wherein the radiopaque marker is positioned at a location that providesan indication of a bifurcation or side-branch position in a vascularanatomy.
 98. The device of claim 94, wherein the balloon is made of anysuitable polymer, non-polymer or composite material thereof.
 99. Thedevice of claim 94, wherein the first average diameter is substantiallythe same along an entire length of the first section.
 100. The device ofclaim 94, wherein the second average diameter is substantially the samealong an entire length of the second section.
 101. The device of claim94, wherein the second lumen includes an inflation and deflationaperture positioned in the first section.
 102. The device of claim 94,wherein the second lumen includes an inflation and deflation aperturepositioned in the first section.
 103. The device of claim 94, wherein atleast a portion of the first section is tapered.
 104. The device ofclaim 94, wherein at least a portion of the second section is tapered.105. The device of claim 94, wherein a radiopaque marker is positionedat a proximal section of the balloon.
 106. The device of claim 94,wherein a radiopaque marker is positioned at a distal portion of theballoon.
 107. The device of claim 94, wherein the catheter body is partof an over-the-wire catheter system.
 108. The device of claim 94,wherein the catheter body is part of a rapid-exchange catheter system.109. The device of claim 94, wherein the device is used for abifurcation or side branch vascular anatomy.
 110. The device of claim94, wherein the first section has a larger length than a length of thesecond section.
 111. The device of claim 94, wherein a length of thesecond is greater than a length of the first section.
 112. The device ofclaim 94, wherein the lengths of the first and second sections are aboutthe same.
 113. A method of treating a vascular bifurcation orside-branch anatomy, comprising: providing a catheter that includes aballoon with a transition section that couples a first section with asecond section, the transition section having a geometry and size toreduce vessel damage when position at a point of vessel bifurcation;mounting a stent in a non-expanded on an exterior of the balloon;positioning the catheter with the stent in a non-expanded state at avascular bifurcation or a vascular side-branch site; inflating theballoon and deploying the stent in an expanded state at the vascularbifurcation or vascular side-branch site; and removing the catheter fromthe vascular bifurcation or a vascular side-branch site.